Pressure UlcerPRELINEMNCT05763654
PMCF Study on the Safety of Linovera Emulsion for the Prevention of Cat-1 Pressure Ulcers, Vascular and DFU
An observational study of Pressure Ulcer, run by B. Braun Medical SA at 1 site in Spain.
Trial summary
To assess the safety of Linovera® Emulsion in the prevention of Grade I Pressure ulcers, Vascular and Diabetic Foot Ulcers. To assess the performance of Linovera® Emulsion for the prevention of stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers. Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Pressure Ulcer
- What is being tested?
- Linovera emulsion
- Type of treatment
- Medical device
- How many people
- 164 participants
- Where
- 1 siteSpain
- Study dates
- 15 Dec 2022to Dec 2023
- How long will I take part?
- 1 Month
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Already described in Inclusion and Exclusion criteria
Who may be able to join
- Age ≥ 18 years
- Signed informed consent
- Patients with the possibility to participate during up 6 month follow-up.
- At least one of these criteria:
- Patients with medium, high or very high risk of amputation due to a vascular or diabetic foot illness.
- Patients with medium, high or very high risk of developing a pressure ulcer due to any neuropathic foot pathology
- Patients with medium, high or very high risk of developing a pressure ulcer following Braden Scale.
Who cannot join
- Age < 18 years
- Known allergies and/or hypersensitivity to any component of Linovera® Emulsion.
- Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures.
- Patients in the terminal stage or receiving chemotherapy.
- Patients with more than 3 active pressure ulcers.
Trial locations and contacts
1 site in 1 country.
Spain1 site, 1 recruiting
- Recruiting
Hospital Alvaro Cunqueiro
Vigo, 36312
Jose Manuel Encisa de Sa, Dr, +34 986 81 11 11, jm.encisa@gmail.com
About this study
Official title: Multicenter, Long-term, Single-arm and Observational PMCF Study on the Safety of Linovera Emulsion for the Prevention of Stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers (PRELINEM)
To assess the safety of Linovera® Emulsion in the prevention of Grade I Pressure ulcers, Vascular and Diabetic Foot Ulcers.
To assess the performance of Linovera® Emulsion for the prevention of stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers.
Read the detailed description
Diverse parameters are to be used to assess the safety and efficacy of Linovera® Emulsion for the prevention of stage 1 pressure ulcer, vascular and diabetic foot ulcers.
This study is designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity as a part of our Post Market Surveillance (PMS).
- Conditions
- Pressure Ulcer
- Being tested
- Linovera emulsion
- Medical subject headings
- Pressure Ulcer
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Linovera emulsionDevice
Apply Linovera emulsion in clinical routine
| Study group | Role | What they receive |
|---|---|---|
| Linovera emulsion | No intervention. Routine clinical practice. Receives: Device: Linovera emulsion |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of adverse events
Number of adverse events
Measured: 1 month
Secondary outcomes (1)
Number of participant developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers
Number of participants developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers
Measured: 1 month
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2023
- Study start15 Dec 2022
- Primary completionDec 2023 (estimated)
- Study completionDec 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pressure UlcerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 164 participants (estimated)
- Target duration
- 1 Month
Sponsor and investigators
- Lead sponsor
- B. Braun Medical SA
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05763654
- Sponsor's protocol ID
- BA-G-H-2201
- Acronym
- PRELINEM
- Status last verified
- Oct 2023
- First submitted
- 25 Nov 2022
- Last updated
- 23 Oct 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Multicenter, Long-term, Single-arm and Observational PMCF Study on the Safety of Linovera Emulsion for the Prevention of Stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers (PRELINEM)
- ClinicalTrials.gov ID
- NCT05763654
- Acronym / sponsor ID
- PRELINEM / BA-G-H-2201
- Conditions
- Pressure Ulcer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 164 participants (estimated)
- Lead sponsor
- B. Braun Medical SAIndustry (pharma, biotech, devices)
- Study start
- 15 Dec 2022 (actual)
- Primary completion
- Dec 2023 (estimated)
- Study completion
- Dec 2023 (estimated)
- First posted
- 10 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To assess the safety of Linovera® Emulsion in the prevention of Grade I Pressure ulcers, Vascular and Diabetic Foot Ulcers.
To assess the performance of Linovera® Emulsion for the prevention of stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers.
Detailed description
Diverse parameters are to be used to assess the safety and efficacy of Linovera® Emulsion for the prevention of stage 1 pressure ulcer, vascular and diabetic foot ulcers.
This study is designed to implement an action within the framework of a proactive Post Market Clinical Follow up (PMCF) activity as a part of our Post Market Surveillance (PMS).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Month
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Linovera emulsion | – | Device: Linovera emulsionNo intervention. Routine clinical practice. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Already described in Inclusion and Exclusion criteria
Key inclusion criteria (7 listed)
- Age ≥ 18 years
- Signed informed consent
- Patients with the possibility to participate during up 6 month follow-up.
- At least one of these criteria:
- Patients with medium, high or very high risk of amputation due to a vascular or diabetic foot illness.
Key exclusion criteria (5 listed)
- Age < 18 years
- Known allergies and/or hypersensitivity to any component of Linovera® Emulsion.
- Any medical or psychological disorder that, in the investigator's opinion, may interfere with the patient's ability to give informed consent and comply with the study procedures.
- Patients in the terminal stage or receiving chemotherapy.
- Patients with more than 3 active pressure ulcers.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Linovera emulsionApply Linovera emulsion in clinical routine | Device | Linovera emulsion |
Primary outcome
Number of adverse events
Time frame: 1 month
Number of adverse events
1 secondary outcome
Number of participant developing stage 1 Pressure Ulcers, Vascular and Diabetic Foot Ulcers
Time frame: 1 month
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Pressure Ulcer, run by B. Braun Medical SA at 1 site in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 23 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Aina Fernández (+34 663 895 945, aina.fernandez@bbraun.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of adverse events (time frame: 1 month). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2023; AzTrials last refreshed its copy on 7 Nov 2026.